FatigueNCT00182780
American Ginseng in Treating Patients With Cancer-Related Fatigue
A study testing American ginseng in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: American ginseng may help relieve cancer-related fatigue. PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- American ginseng
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed cancer
- Experiences cancer-related fatigue, defined as a baseline fatigue score of ≥ 4 on a numerical analogue scale (0-10)
- Fatigue must be present for ≥ 1 month before study entry
- No primary brain cancer, brain metastases, or other CNS malignancy, including CNS lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- Hemoglobin ≥ 11 g/dL
Hepatic
- SGOT ≤ 1.5 times upper limit of normal (ULN)
Renal
- Calcium ≤ 1.2 times ULN
- Creatinine ≤ 1.2 times ULN
Cardiovascular
- No uncontrolled hypertension (i.e., diastolic blood pressure [BP] > 100 mm Hg and/or systolic BP > 160)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No diabetes, defined as receiving oral hypoglycemics or insulin
- No hypersensitivity to ginseng
- No uncontrolled pain, hypothyroidism, or insomnia that is considered to be the primary cause of patient's fatigue
- Not currently under the care of a psychiatrist for documented psychiatric disorder (e.g., severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Concurrent epoetin alfa for treatment of anemia allowed
Chemotherapy
- Concurrent chemotherapy allowed except CHOP therapy
Endocrine therapy
- No concurrent chronic systemic steroids
Radiotherapy
- Not specified
Surgery
- More than 4 weeks since prior major surgery
Other
- No prior ginseng capsules for fatigue
- Prior ginseng-containing teas or drinks purchased at a grocery store allowed
- No concurrent pharmacologic agents for the treatment of fatigue, including any of the following:
- Psychostimulants
- Antidepressants
- Antidepressants used to treat conditions other than fatigue (e.g., hot flashes) are allowed provided the patient has been on a stable dose for ≥ 1 month and plans to continue antidepressant for ≥ 1 month
- No concurrent monoamine oxidase inhibitors
- No concurrent full anticoagulation doses of warfarin or heparin
- A dose of 1 mg/day for preventing catheter clots allowed
About this study
Official title: The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study
RATIONALE: American ginseng may help relieve cancer-related fatigue.
PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue.
Read the detailed description
OBJECTIVES:
Primary
- Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue.
Secondary
- Determine the toxic effects and tolerability of American ginseng in these patients.
- Determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (I or II vs III or IV vs unknown), gender (male vs female), baseline fatigue score (4-7 vs 8-10), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
- Being tested
- American ginseng, Placebo
- Keywords
- fatigue, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American ginsengDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Arm I - American ginseng (low dose) | Experimental | Patients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.
Quality of life is assessed at baseline, every 2 weeks during treatment, and at the end of treatment.
PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months. Receives: Dietary Supplement: American ginseng |
| Arm II - American ginseng (mid-dose) | Experimental | Patients receive oral American ginseng at the mid-dose twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. Receives: Dietary Supplement: American ginseng |
| Arm III - American ginseng (high-dose) | Experimental | Patients receive oral American ginseng at the high dose twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. Receives: Dietary Supplement: American ginseng |
| Arm IV - Placebo | Other | Patients receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue by brief inventory at 4 and 8 weeks of treatment
Measured: at 4 and 8 weeks
Secondary outcomes (2)
Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment
Measured: at 4 and 8 weeks
Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment
Measured: at 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2005
- Primary completion5 Sep 2006
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brent A. Bauer, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182780
- Sponsor's protocol ID
- NCCTG-N03CA
- Other IDs
- NCI-2012-02670, CDR0000440907
- Status last verified
- Oct 2017
- First submitted
- 15 Sep 2005
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer. 2010 Feb;18(2):179-87. doi: 10.1007/s00520-009-0642-2. Epub 2009 May 6.
PubMed 19415341
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00182780
- Acronym / sponsor ID
- NCCTG-N03CA
- Keywords
- fatigue, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Primary completion
- 5 Sep 2006 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: American ginseng may help relieve cancer-related fatigue.
PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue.
Detailed description
OBJECTIVES:
Primary
- Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue.
Secondary
- Determine the toxic effects and tolerability of American ginseng in these patients.
- Determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (I or II vs III or IV vs unknown), gender (male vs female), baseline fatigue score (4-7 vs 8-10), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I - American ginseng (low dose) | Experimental | Dietary Supplement: American ginsengPatients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. Quality of life is assessed at baseline, every 2 weeks during treatment, and at the end of treatment. PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months. |
| Arm II - American ginseng (mid-dose) | Experimental | Dietary Supplement: American ginsengPatients receive oral American ginseng at the mid-dose twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. |
| Arm III - American ginseng (high-dose) | Experimental | Dietary Supplement: American ginsengPatients receive oral American ginseng at the high dose twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. |
| Arm IV - Placebo | Other | Other: PlaceboPatients receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| American ginseng | Dietary supplement | Arm I - American ginseng (low dose), Arm II - American ginseng (mid-dose), Arm III - American ginseng (high-dose) |
| Placebo | Other | Arm IV - Placebo |
Primary outcome
Fatigue by brief inventory at 4 and 8 weeks of treatment
Time frame: at 4 and 8 weeks
2 secondary outcomes
Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment
Time frame: at 4 and 8 weeks
Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment
Time frame: at 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Results publication: PubMed 19415341Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer. 2010 Feb;18(2):179-87. doi: 10.1007/s00520-009-0642-2. Epub 2009 May 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent A. Bauer, MD study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing American ginseng in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by Alliance for Clinical Trials in Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue by brief inventory at 4 and 8 weeks of treatment (time frame: at 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.